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FDA 510(k)

Aspiron(TM) Aspiration Catheter

K-Number: K190619 · 2019-04-29

ApplicantMeril Life Sciences Private Limited
Decision Date2019-04-29
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aspiron(TM) Aspiration Catheter is a medical device manufactured by Meril Life Sciences Private Limited. It received FDA 510(k) clearance on 2019-04-29 under approval number K190619. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspiron(TM) Aspiration Catheter?

Aspiron(TM) Aspiration Catheter is a medical device that received FDA 510(k) clearance on 2019-04-29. It is manufactured by Meril Life Sciences Private Limited. The 510(k) number is K190619.

When was Aspiron(TM) Aspiration Catheter approved by the FDA?

Aspiron(TM) Aspiration Catheter received FDA 510(k) clearance on 2019-04-29, under approval number K190619.

What company makes Aspiron(TM) Aspiration Catheter?

Aspiron(TM) Aspiration Catheter is manufactured by Meril Life Sciences Private Limited.

What is the FDA product code for Aspiron(TM) Aspiration Catheter?

The FDA product code for Aspiron(TM) Aspiration Catheter is QEZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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